510(k) K132596 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
PROPOSED OPTIMUS
| Applicant | Custom Spine, Inc., Parsippany NJ, US |
| Decision | Substantially Equivalent, Apr 11, 2014 |
| Received | Aug 19, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132596
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 22, 2016 | Amendia, Inc Optimus Fixed Awl Terminated |
OVD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.